Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT)

Stroke, Ischemic Clinical Trial

Official title:

Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT): a Prospective, Randomized, Open-label, Blinded-end Point, Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05657457
• Other study ID #: Y (2022) 185
• Status: Recruiting
• Phase: Phase 3
• Start date: March 21, 2023
• Est. completion date: March 15, 2025

Study information

• Verified date: March 2023
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The potential benefit of intraarterial tenecteplase in acute basilar artery occlusion (BAO) patients with successful reperfusion following endovascular treatment (EVT) has not been studied. The current study aimed to explore the efficacy and safety of intraarterial tenecteplase in acute BAO patients with successful reperfusion after EVT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18
• Patients with basilar artery occlusion who received endovascular treatment within 24 hours of estimated time of stroke onset as per BASICS trial definition;
• National Institute of Health Stroke Scale (NIHSS) = 6 before endovascular treatment;
• Successful recanalization (mTICI 2b-3) after endovascular treatment;
• PC-ASPECTS = 6 on CT;
• Absence of parenchymal hematoma on CT images done in the angio suite immediately after the procedure;
• Modified Rankin Scale score before stroke onset = 3;
• Signed informed consent by patient or their legally authorized representative.

Exclusion Criteria:

• baseline PC ASPECTS < 5 on CT;
• More than six retrieval attempts in the same vessel;
• Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
• Coagulation disorders, systemic hemorrhagic diathesis, thrombocytopenia (<100000/mm3), or INR > 1.7;
• Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
• After recanalization, severe and sustained (i.e., > 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg) refractory to antihypertensive medication;
• Patients with contraindication or allergic to any ingredient of drugs in our study
• Pregnancy, plan to get pregnant or during lactation
• The estimated life expectancy is less than 6 months due to other serious diseases;
• Other conditions unsuitable for this clinical study assessed by researcher.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke, Ischemic

Intervention

Drug:
• Tenecteplase
intra-arterial tenecteplase

Locations

Country	Name	City	State
China	General Hospital of Northern Theater Command	ShenYang

Sponsors (2)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region	Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of favorable functional outcome	favorable functional outcome is defined as a modified Rankin Scale (mRS) score of 0 to 3	Day 90
Secondary	proportion of patients with an improved modified thrombolysis in cerebral infarction score		immediately after intraarterial TNK administration or at the end of endovascular treatment
Secondary	the proportion of patients with modified Rankin Score (mRS) 0 to 1	mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.	Day 90
Secondary	the proportion of patients with modified Rankin Score (mRS) 0 to 2	mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.	Day 90
Secondary	ordinal distribution of modified Rankin Score (mRS)	mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.	Day 90
Secondary	change in modified Rankin Score (mRS) compared with premorbid mRS	mRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.	Day 90
Secondary	change in National Institute of Health stroke scale (NIHSS)	NIHSS scores range from 0 to 42, with higher scores indicating more severe neurological deficit	24 (-6/+24) hours
Secondary	proportion of early neurological improvement	early neurological improvement is defined as a NIHSS decrease =4	24 (-6/+24) hours
Secondary	change in the cerebral circulation time		immediately after tenecteplase
Secondary	the occurrence rate of composite events of recurrent stroke, cardiovascular or cerebrovascular events		Day 90
Secondary	proportion of sympomatic intracranial hemorrhage	sympomatic intracranial hemorrhage is defined as a NIHSS increase =4 caused by intracranial hemorrhage	24 (-6/+24) hours
Secondary	proportion of intraparenchymal hemorrhage	intraparenchymal hemorrhage was defined as confluent bleeding occupying and causing mass effect	24 (-6/+24) hours
Secondary	the percentage of severe adverse events		24 (-6/+24) hours
Secondary	cerebral edema	cerebral edema was measure by the mount of midline shift of the brain on neuroimaging	24 (-6/+24) hours
Secondary	all-cause mortality		10 days
Secondary	the number of tenecteplase infusions interrupted due to suspected active bleeding		during endovascular treatment (up to 2 hours)